—#74717

Product

Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, France. Single use devices intended for cementless fixation within the prepared acetabulum. Intended for use with the mating Trident Polyethylen Cup Inserts.

FDA product code: MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K013676
Affected lot / code info: Product Number: 508-11-72J; Lot Number: 20282301.

Why it was recalled

Stryker Orthopaedics became aware that Trident Hemispherical Shells, Catalog Number 508-11-74J, are actually marked and labeled as Catalog Number 598-11-72J, Lot Code 20282301

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Stryker Orthopaedics issued an "Important Market Withdrawal" notice via Federal Express dated May 29, 2007. Consignees were asked to locate and return affected product and fax the attached Product Accountability Form to 1-201-831-6069. For further questions, contact Stryker Orthopaedics at 1-201-831-5825.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Distributed to 2 Stryker branches.

Timeline

Recall initiated: 2007-05-29
Posted by FDA: 2009-08-13
Terminated: 2009-08-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74717. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.